510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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IREClass I

Joint, Elbow, External Limb Component, Powered

21 CFR 890.3420 / Physical Medicine
FDA source (opens on fda.gov)

IRE is the FDA product code for Joint, Elbow, External Limb Component, Powered, a class I device type, regulated under 21 CFR 890.3420. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
IRE
Device name
Joint, Elbow, External Limb Component, Powered
Regulation
21 CFR 890.3420
Device class
Class I
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code IRE

By decision year
2 clearances under product code IRE with a decision year between 1980 and 1982, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code IRE by decision year
YearClearances
19801
19821

Applicants with the most clearances

Product code IRE
Applicants holding the most 510(k) clearances under product code IRE
ApplicantClearances
Hosmer Dorrance Corp.1
Motion Control, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order